Pharmacy Prior Authorization Criteria

Riluzole Products

Indications for Prior Authorization

Tiglutik (riluzole suspension), Teglutik (riluzole suspension)

• For diagnosis of Amyotrophic Lateral Sclerosis (ALS)
  Indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Criteria

Teglutik, Tiglutik

Step Therapy

Length of Approval: When approved; no reauthorization required

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to generic riluzole tablets

P & T Revisions

2026-08-24, 2026-04-16, 2026-03-03, 2025-12-24, 2025-12-18, 2025-12-18, 2025-07-03, 2024-07-02, 2024-03-06, 2024-01-04, 2023-06-07, 2022-07-08, 2021-10-05, 2021-07-22, 2021-05-21, 2020-07-08, 2019-10-29

References

1. Tiglutik Prescribing Information. EDW Pharma, Inc. Paoli, PA. July 2026.
2. Teglutik Prescribing Information. EDW Pharma, Inc. Paoli, PA. December 2025.

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Revision History

• 2026-08-24: 2026 annual review: No criteria changes. Removed obsolete Rilutek and Exservan products and their criteria from guideline.
• 2026-04-16: Change from PA review type to ST
• 2026-03-03: Removing reauthorization requirement as part of extended reauthorization program
• 2025-12-24: Remove EHB formulary from guideline.
• 2025-12-18: No criteria change, bulk copy oRX-EHB
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-07-03: 2025 Annual Review - no changes
• 2024-07-02: 2024 Annual Review - updated NF criteria and references
• 2024-03-06: Addition of Teglutik as a target and as a preferred option to Exservan criteria
• 2024-01-04: Removed generic riluzole as a target
• 2023-06-07: 2023 Annual Review - no changes
• 2022-07-08: 2022 Annual Review- no criteria changes
• 2021-10-05: Updated guideline. Added NF section and addition of Tiglutik as t/f product to Exservan
• 2021-07-22: Renamed guideline "Riluzole Products". Added Exservan film to guideline mirroring criteria for brand Rilutek and Tigultik. 2021 Annual Review.
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-07-08: 2020 Annual Review, no changes to criteria, background updates only.
• 2019-10-29: Updated guideline. Switching to Specialty product. SL 10.07.19

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